Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: “Subjects will be randomized 1:1 to receive Lambda 180 mcg SC or saline injection”
Comment: Allocation sequence probably random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: “Single blind”
Comment: only participants were blinded Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest. Hence, no information on whether deviations arose because of the trial context. Our analysis for the (binary) outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be some concernsfor the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Serious adverse events. |
| Missing outcome data |
Low |
Comment: 14 participants randomized; 14 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Serious adverse events |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) MORTALITY.VIRAL NEGATIVE CONVERSION Observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28).Incidence of viral negative conversion (D7) SERIOUS ADVERSE EVENTS The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected events, which can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcomes: Serious adverse events |
| Selection of the reported results |
Some concerns |
Comment: The protocol, statistical analysis plan (dated 7 June 2021), and registry consulted up to version dated 22 June 2020.
MORTALITY Mortality outcome was not pre-specified in the protocol/SAP/registry, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). VIRAL NEGATIVE CONVERSION Outcome pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Incidence of viral negative conversion (D7). SERIOUS ADVERSE EVENTS Outcome not pre-specified No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Serious adverse events. |
| Overall risk of bias |
Some concerns |